Design Engineer II

Nissha Medical Technologies is excited to be hiring for a Design Engineer II - Electrical/Electronics to join our engineering team at our new site in Nashville, TN. The primary responsibility of the job is to provide intermediate level technical contribution to the design and development of Medical Device product solutions based on the design inputs provided by the customer requirements. These product solutions may be systems that are mechanically or electromechanically based. The design process utilized shall be in compliance with Quality System and standard operating procedures of Nissha Medical Technologies. This role will have a primary focus on applications that incorporate electronics, PCB technologies, Flex circuit technology, and the quality requirements of PCBA/Flex Circuits.

ESSENTIAL JOB FUNCTIONS:

• Follows all employee guidelines and Quality Systems Regulations (QSR's) as defined by NMT's practices, policies and Standard Operating Procedures (SOP's) to ensure that customer requirements and FDA (or equivalent) regulations are met.
• Demonstrates knowledge and acts in accordance with NMT's Employee Guidelines and applicable quality standards as outlined in NMT's Quality Manual.
• Develop product specifications derived from customer requirements
• Conceptualize new product solutions that are capable of meeting customer requirements based on product specifications. These solutions may include principles of solid mechanics, fluids mechanics, thermodynamics, and thermal mechanics. These solutions may also require integration of electrical and software elements.
• Perform engineering analysis as a means of verifying that product concepts have engineering merit and have a high likelihood of meeting the product specifications.
• Perform detailed design of product solutions including CAD Modeling, Design for Manufacturability and Assembly, Material selection, Circuit Design, Electronic Part Selection, and Drawing Specifications..
• Develop detailed drawing of components and assemblies identifying critical criteria to insure product quality.
• Identify suppliers of components and procure prototype component samples.
• Perform initial engineering builds of design prototypes.
• Perform prototype evaluations and debug samples as required.
• Develop test methods and procedures for verifying that a design meets the product specifications.
• Prepare protocols and reports of various types included as part of design verification.
• Develop procedures and instructions for assembling product designs.
• Specify or modify production processing equipment required for manufacturing the product.
• Research and develop custom manufacturing processes as required
• Design, fabricate, and verify the installation of assembly fixturing and manufacturing aids.
• Identify, document, and verify critical in-process and final acceptance product quality criteria.
• Verify and validate production equipment, processes, and test methods.
• Support and participate in the risk management process required by the medical device industry
• Support, guide, and train production personnel in learning the process assembly instructions for the product design.
• Supports the maintenance of the Engineering lab space by managing calibration of test equipment, maintaining orderly workspaces, and requisitioning management for procuring required lab materials.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
• Manages and communicates with customers and suppliers in a professional manner thereby maintaining the company's quality reputation.
• Develops Master Validation plans including IQ, OQ, PQ, PPQ, and Gage R&Rs. Able to execute process validations as a technical lead.
• Other duties as assigned.

REQUIREMENTS:

• At a minimum this role requires a Bachelor's Degree in an Engineering Discipline (preferably Mechanical, Biomedical, Aeronautical or Electrical) with a minimum of a minor in Electronic Technology or Electrical Engineering.
• 3-5 years of Design related experience is preferred but not required. Internship experience will be considered on a case by case basis.
• Communication Skills, specifically the ability to convey technical information effectively in both verbal and written medium.
• Computer skills to include Microsoft Word, Powerpoint, Excel, SolidWorks. Minitab, Altium or similar for circuit design/schematics, Creo/Pro Engineer (preferred), MathCAD (preferred), and Marc/Mentat or similar CAE Software (preferred).
• Working knowledge of Dimensioning and Tolerancing to ASME Y14.5 is preferred.
• Has a desire to gain experience designing disposable multicomponent mechanical systems with between 15-50 components
• Working knowledge of Engineering Statistics is preferred.
• Working knowledge of IEC60601-1-1 and sub-standards is preferred.
• Understanding of material selections in PCB substrates including final PCBA coatings and Flex circuit substrate selection and ink selections for trace and dielectric layers.
• Skill in engineering analysis in specific areas of study including Mechanics of Materials, Strength of Materials, Static Analysis, Dynamics, and Mechanism Analysis is required.
• Basic understanding of Plastics and Metals including processes for manufacturing these components for the healthcare industry is preferred.
• Basic understanding of the fundamentals of Finite Element analysis is preferred.
• Understanding basic methods of inspection is preferred.
• Ability to conceptualize and document creative mechanical solutions to challenging problems are required.
• Physical hand assembly common to the production environment is required for this position.
• Ability to use basic machine shop equipment is required for this position. Use of drill presses, grinding wheels, manual lathes, etc. is a must.
• Ability to perform testing, collect data, and analyze data is required.
• Working knowledge of 21 CFR 820/ ISO13485 Design Controls.
• Working knowledge of Process development and Process Validation.

Nissha Medical Technologies is committed to fair, competitive, and market-informed pay for our employees. The pay range for this position is $80,000-95,000 Annual (USD). The successful candidate's particular combination of knowledge, skills, and experience will inform their specific compensation.

Why choose Nissha to build your career?

At Nissha, you can be assured that you will be part of a dynamic, diverse team that is committed to bringing the best versions of ourselves each and every day. We recently received the "General Excellence" manufacturing award from Buffalo Business First, which highlights our dedication to quality, innovation, and sustainability. This recognition celebrates the hard work of our team in producing high-quality medical devices that meet industry standards and enhance patient care. If you are looking for meaningful work that motivates and inspires, you've come to the right place!

What we offer that you'll love...

• Company Culture: At Nissha, we pride ourselves on cultivating an atmosphere of teamwork where all associates feel heard and valued. We may not all think the same, and we wouldn't have it any other way.
• Diversity & Inclusion: We are committed to equity, racial justice, and equal opportunity for all.
• Training and Development opportunities: Because we foster a culture of continuing education. Let's learn and grow together!
• Team Building, Connection, and Relationships: We support each other, celebrate our achievements and milestones together, and have FUN.
• Retirement: We know you want to retire comfortably and we're here to help! Nissha offers a 401(k) Retirement Plan with an attractive employer contribution.
• Time Away from Work: Whether it is vacation or sick leave, we all need time to recharge. Paid time off is an essential associate benefit and a pillar of self-care.
• Engagement Activities: Recognition isn't just a once-a-year occurrence at Nissha. We celebrate our team members year-round with summer picnics, holiday parties, and employee spotlight events, just to name a few.
• Commitment to Wellness: We offer various opportunities to learn about your health, be healthier, and get rewarded for your healthy lifestyle by offering reduced medical premiums.

And so much MORE!